NIFEDIPINE - Generic Drug Details
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What are the generic sources for nifedipine and what is the scope of freedom to operate?
Nifedipine
is the generic ingredient in six branded drugs marketed by Bayer Pharms, Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Leading, Teva, Pfizer, Norwich, Watson Labs, Watson Labs Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Mylan, Novast Labs, Osmotica Pharm Us, Par Pharm, Rising, Spil, Twi Pharms, Valeant Pharms North, Vitruvias, and Zydus Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-nine drug master file entries for nifedipine. Thirty-seven suppliers are listed for this compound.
Summary for NIFEDIPINE
US Patents: | 0 |
Tradenames: | 6 |
Applicants: | 27 |
NDAs: | 36 |
Drug Master File Entries: | 39 |
Finished Product Suppliers / Packagers: | 37 |
Raw Ingredient (Bulk) Api Vendors: | 165 |
Clinical Trials: | 165 |
Patent Applications: | 6,703 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for NIFEDIPINE |
Drug Sales Revenues: | Drug sales revenues for NIFEDIPINE |
What excipients (inactive ingredients) are in NIFEDIPINE? | NIFEDIPINE excipients list |
DailyMed Link: | NIFEDIPINE at DailyMed |
Recent Clinical Trials for NIFEDIPINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Marshall University | Phase 2 |
Queen Mary University of London | N/A |
Medical College of Wisconsin | Phase 3 |
Pharmacology for NIFEDIPINE
Drug Class | Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for NIFEDIPINE
Anatomical Therapeutic Chemical (ATC) Classes for NIFEDIPINE
US Patents and Regulatory Information for NIFEDIPINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Twi Pharms | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 203126-001 | Apr 3, 2014 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Martec Usa Llc | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 075414-003 | Mar 23, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alembic | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 216896-003 | Nov 18, 2022 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 213361-002 | Jul 19, 2021 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NIFEDIPINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-003 | Sep 6, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | PROCARDIA | nifedipine | CAPSULE;ORAL | 018482-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-002 | Sep 6, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-001 | Sep 6, 1989 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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